Project Name:
Safer Use of Antipsychotics in Youth (SUAY)

Principal Investigator:
Robert Penfold, PhD

Principal Investigator Contact Information:
penfold.r@ghc.org

Principal Investigator institution:
Kaiser Permanente Washington Health Research Institute

Funder
NIMH

Funding Period:
Base period: 04/2016 – 12/2016
Option period 1: 12/25/16-12/24/17
Option period 2: 12/25/17-06/24/2021

Abstract:
This study proposes to test a quality improvement research program. The project is inspired by the Partnership Access Line (PAL) and Second Opinion program operated for the Washington State Medicaid program. PAL was established to bring rapid child mental health consultation access into underserved areas of WA State. Under the program, a mandatory Second Opinion review protocol is triggered for new antipsychotics prescriptions when a set of pre-established criteria are met. SUAY is a step-wise research contract with 3 separately-funded phases: (1) planning and development, (2) feasibility pilot study at 2 sites, and (3) full scale pragmatic effectiveness trial at 4 sites. The usual care arm is primarily observational only. The only change from standard usual care is a best practice alert reminding providers of Choosing Wisely® guidelines when prescribing antipsychotics for youth. The enhanced usual care arm will consist of a more robust best practice alert informing prescribers that the order will be reviewed by a child and adolescent psychiatrist if entered into Epic and offering the provider the opportunity to proactively request a second opinion consultation and behavioral health access support. Patients with an enhanced usual care arm prescriber will be offered 6 months of behavioral health navigation to support access and engagement with therapy in the health system and 4-6 sessions of brief telemental health (clinic-to-home) therapy to bridge wait times to access in-person therapy in the delivery system. Outcomes will be assessed at 6 months.

Contract Number:
HHSN271201600002C

Participating Sites:
Kaiser Permanente Washington (KPWA)
Seattle Children’s Hospital (SCH)
Kaiser Permanente Colorado (KPCO)
Henry Ford Health System (HFHS) (base period and option period 1)
Kaiser Permanente Northwest (KPNW) (option period 2)
Nationwide Children’s Hospital (NCH) / Partners for Kids (PFK)
University of Washington (UW)

Investigators:
Robert Penfold, PhD – Kaiser Permanente Washington Health Research Institute
Greg Simon, MD, MPH – Kaiser Permanente Washington Health Research Institute
James Ralston, MD, MPH – Kaiser Permanente Washington Health Research Institute
Clarissa Hsu, PhD – Kaiser Permanente Washington Health Research Institute
Rebecca Yates Coley, PhD – Kaiser Permanente Washington Health Research Institute
Tobias Dang, MD – Kaiser Permanente Washington Behavioral Health Services
Robert Hilt, MD – Seattle Children’s Hospital
Kathleen Myers, MD – Seattle Children’s Hospital
Kelly Kelleher, MD – Nationwide Children’s Hospital (NCH) /Partners for Kids (PFK)
Brian Ahmedani, PhD – Henry Ford Health System (base period and option period 1)
Arne Beck, PhD – Kaiser Permanente Colorado
Bobbi Jo Yarborough, PhD – Kaiser Permanente Northwest
Andrea Hartzler, PhD – University of Washington (base period and option period 1)
Paul Fishman, PhD – University of Washington

Major Goals:
Base period (8 months): Develop a treatment algorithm and step-by-step clinical workflow that aims to promote the safer use of antipsychotics in youth aged 3-17 years who do not have a psychotic disorder, autism spectrum disorder, or intellectual disability.  Base period activities include convening a consensus panel of national experts to develop the treatment algorithm; interviewing youth, parents, and prescriber clinicians; conducting user-centered design sessions with prescribing clinicians and psychiatrists; and preparing for an option period 1 pilot study.

 

Option period 1 (12 months): Conduct a pilot study to test the feasibility, acceptability, reproducibility and implementation of the intervention and workflow in two health systems (20 patients per clinical site).  Kaiser Permanente Washington and Nationwide Children’s Hospital will participate in the pilot.

Option period 2 (3 years, 6 months): Conduct a full-scale pragmatic effectiveness study comparing usual care to enhanced usual care at four health system (200 patients enrolled per clinical site). Kaiser Permanente Washington, Nationwide Children’s Hospital, Kaiser Permanente Northwest, and Kaiser Permanente Colorado will participate in the pragmatic trial.

Description of study sample:
Provider subjects: The study will pre-randomize clinicians credentialed to prescribe medications in the health systems’ internal deliver system electronic medical record. Providers will be randomized to one of two arms: (1) usual care control and (2) intervention arms.

Patient subjects: Patients between the ages of 3 and 17 not already prescribed an outpatient antipsychotic and not suffering from a psychotic disorder, mania, autism spectrum disorder or intellectual disability. Patient subjects will be added to a study log when a randomized provider enters an antipsychotic medication order for them in Epic.

Current Status:
The pragmatic trial fielded at Kaiser Permanente Washington in March 2018, at Kaiser Permanente Colorado in June 2018 and at Nationwide Children’s Hospital in July 2018. Henry Ford Health System’s IRB did not approval the protocol due to concerns granting a waiver of consent for providers. The contract was modified to replace Henry Ford Health System with Kaiser Permanente Northwest as a fourth recruitment site. Northwest is aggressively pursuing a January 2019 launch date. The end date of the contract may be extended to allow for a longer recruitment period given delays to fielding. The study had enrolled a total of 111 subjects as of September 24, 2018, or 14% of the target 800 subjects.

Study Registration:
The trial is registered in ClinicalTrials.gov under record number NCT03448575.

Publications:
One manuscript is under review. Two manuscripts are currently in development.

Resources:

  • Clinical guidelines developed by a national panel of experts for the safer prescribing of antipsychotic prescribing in youth.
  • Epic build package.
  • Study protocol and manual of procedures.

What’s next?
Recruitment for the large pragmatic effectiveness study will continue into Spring 2020 at Kaiser Permanente Washington, Nationwide Children’s Hospital, Kaiser Permanente Colorado, and Kaiser Permanente Northwest. Data and safety monitoring board reports will continue to be prepared and delivered three times per year.